BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3765176 · Received April 22, 2014

    Report

    Report Number
    2953200-2014-00792
    Event Type
    Death
    Date Received
    April 22, 2014
    Date of Event
    July 12, 2013
    Report Date
    March 28, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN. (B)(4). EVALUATION CONCLUSION: OFF-LABEL (IMPLANTING IN ZONE 0).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. EARLY EXPERIENCE WITH OFF-THE-SHELF ENDOGRAFTS USING A ZONE 0 PROXIMAL LANDING SITE TO TREAT THE ASCENDING AORTA AND ARCH. RODRIGO C. BERNARDES, , TULIO P. NAVARRO, FERNANDO R. REIS, LUIZ C. M. LIMA, ERNESTO L. MONTEIRO, RICARDO J. PROCOPIO, FRANCESCO E. BOTELHO, AND ALAN DARDIK. J THORAC CARDIOVASC SURG 2013-:1-8 ON UNKNOWN DATES BETWEEN 2007 AND 2012, AN UNKNOWN VALIANT STENT GRAFT WAS IMPLANTED IN ZONE 0 FOR THE ENDOVASCULAR TREATMENT OF A PENETRATING ULCER IN THE DISTAL THIRD OF THE ASCENDING AORTA. THE MAXIMUM AORTIC DIAMETER WAS 64MM. THE PROXIMAL AND DISTAL AORTIC NECK MEASURED 30MM IN DIAMETER. THE PATIENT DEVELOPED ACUTE AORTIC INSUFFICIENCY IMMEDIATELY AFTER DEPLOYMENT OF THE ENDOGRAFT BECAUSE OF ARREST OF THE NONCORONARY LEAFLET OF THE AORTIC VALVE BY THE DISTAL BARE STENT RING. THE PATIENT UNDERWENT IMMEDIATE CONVERSION TO OPEN SURGERY WITH CARDIOPULMONARY BYPASS BUT DID NOT SURVIVE. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: SURGICAL CONVERSION, DEATH, BYPASS. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: ACUTE TYPE A AORTIC SYNDROMES AND ITS CHRONIC COMPLICATIONS ARE FATAL DISEASES TRADITIONALLY TREATED BY OPEN SURGERY, WITH HIGH MORTALITY RATES. AN ENDOVASCULAR APPROACH TO THE ASCENDING AORTA COULD REDUCE THE MORBIDITY AND MORTALITY ASSOCIATED WITH OPEN SURGERY. OUR AIM WAS TO REPORT OUR INITIAL EXPERIENCE IN TREATING ASCENDING AORTIC PATHOLOGY USING COMMERCIALLY AVAILABLE DESCENDING THORACIC ENDOGRAFTS. METHODS: FROM 2007 TO 2012, 69 PATIENTS PRESENTED TO OUR CENTER IN BELO HORIZONTE, BRAZIL, WITH ACUTE TYPE A AORTIC SYNDROME OR ITS CHRONIC COMPLICATIONS. OF THE 69 PATIENTS, 8 HIGH-RISK PATIENTS HAD SUITABLE ANATOMY, AND 7 AGREED TO PARTICIPATE IN THE PRESENT STUDY. RESULTS: OF THE 7 PATIENTS, 4 HAD PENETRATING ULCERS, 2 HAD ACUTE DISSECTIONS, AND 1 HAD CHRONIC DISSECTION WITH AN ANEURYSM. THE TE CHNICAL SUCCESS RATE WAS 87%, WITH 1 INTRAOPERATIVE DEATH FROM ACUTE AORTIC VALVE INSUFFICIENCY. THE PROXIMAL LANDING ZONE WAS, ON AVERAGE, 21 MM ABOVE THE AORTIC VALVE IN ALL PATIENTS. THREE PATIENTS REQUIRED INTRAOPERATIVE CERVICAL DEBRANCHING DUE TO A LESION IN THE DISTAL THIRD OF THE ASCENDING AORTA, COMPROMISING THE SUPRA-AORTIC BRANCHES. THE DISTAL LANDING ZONE WAS AT ZONE 0 IN 4 PATIENTS, ZONE 2 IN 1 PATIENT, AND IN ZONE 4 IN 2 PATIENTS. THE MEAN FOLLOW-UP WAS 26.3 MONTHS. TWO REPEAT DISSECTIONS DEVELOPED AN AVERAGE OF 2 MONTHS AFTER TREATMENT. BOTH PRESENTED WITH ACUTE DISSECTION THAT WAS TREATED WITH ADDITIONAL OPEN SURGERY AND BOTH PATIENTS SURVIVED. THEREAFTER, NO PATIENT HAD PRESENTED AGAIN WITH AN ACUTE AORTIC SYNDROME OR OTHER REFERABLE SYMPTOMS. CONCLUSIONS: ENDOVASCULAR TREATMENT OF THE ASCENDING AORTA IS FEASIBLE. WE HAD 4 GOOD MID-TERM RESULTS IN 7 PATIENTS WHO HAD PRESENTED WITH PENETRATING ULCERS OR ANEURYSM FORMATION. ACUTE DISSECTIONS SEEM TO BE MORE UNSTABLE, AND ADDITIONAL RESEARCH IS MANDATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243164 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death| R